Transmedics Group Inc (TMDX) 2025 Q4 法說會逐字稿

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使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good afternoon and welcome to Transmedic's fourth quarter 2025 earnings conference call.

    下午好,歡迎參加Transmedic 2025年第四季財報電話會議。

  • (Operator Instructions)

    (操作說明)

  • I would now like to turn the call over to Elaine Morgan from the Gil Martin Group for a few introductory comps.

    現在我想把電話交給吉爾馬丁集團的伊萊恩摩根,讓她介紹幾個入門級的案例。

  • Elaine Morgan

    Elaine Morgan

  • Thank you. Earlier today, Transmedics released financial results for the quarter and full year ended December 31, 2025. A copy of the press release is available on the company's website. Before we begin, I would like to remind you that management will make statements during this call, including during the question-and-answer portion of the call that includes forward-looking statements within the meaning of federal securities laws. Any statements made during this call that relate to future events, results, or performance, including expectations or predictions are forward-looking statements.

    謝謝。今天早些時候,Transmedics 發布了截至 2025 年 12 月 31 日的季度和全年財務業績。新聞稿副本可在公司網站上查閱。在會議開始之前,我想提醒各位,管理層將在本次電話會議中發表聲明,包括在問答環節中發表的聲明,這些聲明可能包含聯邦證券法意義上的前瞻性陳述。本次電話會議中任何與未來事件、結果或績效有關的陳述,包括預期或預測,均為前瞻性陳述。

  • All forward-looking statements, including without limitation, our examination of operating trends, the potential commercial opportunity of our products and services, the potential timing, benefits or outcomes of new clinical programs, and our future financial expectations which include expectations for growth in our organization and guidance and or expectations. In revenue, gross margins, and operating expenses in 2026 and beyond are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. Additional information regarding these risks and uncertainties appears under the heading risk factors of our 100 filed with the Securities and Exchange Commission on February 24, 2026 and our subsequent SEC filings and the forward-looking statements included in today's earnings press release, which are available at www.sec.government and our website at www.transmedics.com. Transmedic proclaims any intention or obligation except as required by law to update or revise any financial projections, expectations, predictions, or forward-looking statements, whether because of new information, future. Events or developments or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, February 24, 2026.

    所有前瞻性陳述,包括但不限於我們對營運趨勢的考察、我們產品和服務的潛在商業機會、新臨床項目的潛在時間、益處或結果,以及我們未來的財務預期(包括對我們組織成長的預期和指導和/或預期)。2026 年及以後的收入、毛利率和營運費用均基於我們目前的估計和各種假設。這些聲明涉及重大風險和不確定性,可能導致實際結果或事件與這些前瞻性聲明中預期或暗示的結果或事件有重大差異。因此,您不應過度依賴這些說法。有關這些風險和不確定性的更多信息,請參閱我們於2026年2月24日向美國證券交易委員會提交的100份文件中“風險因素”部分,以及我們隨後提交給美國證券交易委員會的文件和今天發布的盈利新聞稿中包含的前瞻性陳述。這些文件可在www.sec.government和我們的網站www.transmedics.com上查閱。除法律要求外,Transmedic聲明不承擔任何更新或修訂任何財務預測、預期、預估或前瞻性陳述的意圖或義務,無論是因為新資訊或未來情況。事件、發展或其他。本次電話會議包含有時效性的信息,僅截至 2026 年 2 月 24 日直播當天的資訊準確無誤。

  • And with that, I will now turn the call over to Waleed Hassanein, President and Chief Executive Officer.

    接下來,我將把電話交給總裁兼執行長瓦利德·哈桑內因。

  • Waleed Hassanein - President and Chief Executive Officer

    Waleed Hassanein - President and Chief Executive Officer

  • Thank you so much, Elaine. Good afternoon, everyone, and welcome to Transmedic's fourth quarter and full year 2025 earnings call. Joining me today is Gerardo Hernandez, our Chief Financial Officer.

    非常感謝你,伊萊恩。各位下午好,歡迎參加 Transmedic 2025 年第四季及全年業績電話會議。今天和我一起出席的是我們的財務長傑拉爾多·埃爾南德斯。

  • I am thrilled to be here tonight reporting our 4th quarter performance, capping off an outstanding year for Transmedics as we delivered our best operational performance to date.

    今晚我非常高興能在這裡報告我們第四季度的業績,這為Transmedics精彩的一年畫上了圓滿的句號,我們取得了迄今為止最好的營運業績。

  • These results were achieved despite external challenges earlier in the year that were designed to distract and disrupt our sustained and transformational growth.

    儘管今年稍早我們面臨著旨在分散注意力、擾亂我們持續轉型發展的外部挑戰,但我們仍然取得了這些成果。

  • I'm extremely proud of the resilience of our team and our business.

    我為我們團隊和公司的韌性感到無比自豪。

  • In addition, I'm grateful to our global clinical users for their continued partnership with Transmedics and their trust in our OCSNOP program throughout the year.

    此外,我還要感謝我們全球的臨床使用者與 Transmedics 的持續合作,以及他們一年來對我們的 OCSNOP 計畫的信任。

  • Based on our performance in 2025 and our continued investment in expanding the caliber and the breadth of our team, I am growing exceedingly confident in Transmedics' ability to overcome future challenges as we continue to innovate and disrupt antiquated and inefficient transplant processes in the US and around the world.

    基於我們在 2025 年的業績以及我們不斷投資提升團隊素質和拓展團隊規模,我對 Transmedics 克服未來挑戰的能力越來越有信心,我們將繼續創新,顛覆美國乃至全世界陳舊低效的移植流程。

  • We are highly motivated and inspired by our mission to expand the utilization of available donor organs for transplantation while aiming to deliver the absolute best possible clinical outcomes for transplant patients worldwide.

    我們的使命是擴大可用捐贈器官在移植中的使用率,同時力求為全球移植患者提供最佳的臨床療效,激勵我們不斷前進。

  • We strongly believe that Transmedics is just getting started, and we have our sights focused on new peaks which we will share with you on today's call.

    我們堅信 Transmedics 才剛起步,我們的目標是攀登新的高峰,我們將在今天的電話會議上與大家分享這些目標。

  • Now let me proceed with discussing our business performance.

    現在讓我來談談我們的業務表現。

  • On our last call, we stated our expectation that 3Q seasonality in US transplant activities would be transient and that we should recover in 4Q.

    在上次電話會議上,我們表示,我們預計美國移植活動的第三季季節性波動是暫時的,第四季應該會恢復正常。

  • Today we're excited to report that 4Q results that validate our views. 4Q 2025 was a banner quarter for our business and allowed us to conclude 2025 on a very high note. Here are the key operational highlights for 4Q 2025.

    今天我們很高興地宣布,第四季業績證實了我們的觀點。2025 年第四季是我們業務的里程碑式季度,也讓我們以非常優異的成績為 2025 年畫上了圓滿的句號。以下是 2025 年第四季的主要營運亮點。

  • Total revenue for 4Q25 was $160.8 million representing approximately 32% growth year over year and approximately 12% sequential growth from pre-Q 2025.

    2025 年第四季總營收為 1.608 億美元,年增約 32%,較 2025 年上一季較上季成長約 12%。

  • US transplant revenue grew approximately 11% sequentially to 155 million while all US transplant revenue grew approximately 33% sequentially to 5 million.

    美國器官移植收入較上季成長約 11%,達到 1.55 億美元,而美國所有器官移植收入較上季成長約 33%,達到 500 萬美元。

  • Finally, we delivered an operating profit of approximately $21.3 million in 4Q, representing approximately 13.2% of total revenue for fourth quarter while making substantial investments to fuel our growth.

    最後,我們在第四季度實現了約 2,130 萬美元的營業利潤,約佔第四季度總收入的 13.2%,同時我們也進行了大量投資以推動成長。

  • Now let me provide the financial results for the full year 2025.

    現在讓我來提供2025年全年的財務表現。

  • Total revenue for the full year 2025 was $605.5 million representing approximately 37% growth year over year.

    2025 年全年總營收為 6.055 億美元,較去年同期成長約 37%。

  • We delivered operating profit of approximately $108.6 million representing approximately 18% of total revenue for the full year 2025.

    2025 年全年,我們實現了約 1.086 億美元的營業利潤,約佔總收入的 18%。

  • Importantly, we ended the year with approximately $488.4 million of cash and cash equivalents.

    重要的是,到年底我們持有約 4.884 億美元的現金及現金等價物。

  • Shifting now to Transmedics, transplant, logistics, infrastructure and performance.

    現在轉向Transmedics、移植、物流、基礎設施和績效。

  • Transmedics transplant logistics service revenue for 4Q was approximately $28.6 million up from $21.7 million in 4Q 2024, representing approximately 32% year over year growth and up from $27.2 million in 3Q, representing approximately 5% sequential growth.

    Transmedics 在第四季移植物流服務營收約 2,860 萬美元,高於 2024 年第四季的 2,170 萬美元,年成長約 32%;高於第三季的 2,720 萬美元,季增約 5%。

  • Throughout 4Q, we owned and operated 22 aircraft. In Q4, we maintain coverage of approximately 80% of our NOP missions requiring air transport compared to 75% in the same period in 2024.

    第四季度,我們擁有並營運了 22 架飛機。第四季度,我們維持了約 80% 的 NOP 任務空運覆蓋率,而 2024 年同期這一比例為 75%。

  • We are very pleased by our strong performance in 4Q and full year 2025 that was fueled by growing OCS case volume and increased clinical adoption.

    我們對 2025 年第四季和全年的強勁業績感到非常滿意,這得益於 OCS 病例數量的成長和臨床應用的增加。

  • Importantly, as we predicted, our performance enabled growth in overall US liver and heart transplant volumes for the third consecutive year, driven primarily by OCSNOP cases. This is really unprecedented and frankly humbling.

    重要的是,正如我們預測的那樣,我們的出色表現使得美國肝臟和心臟移植總量連續第三年增長,這主要得益於 OCSNOP 病例的推動。這真是史無前例,坦白說,令人感到慚愧。

  • As we do every year, I would like to share full year OCS transplant volumes and overall US transplants per organ.

    和往年一樣,我想和大家分享一下 OCS 全年的移植量以及美國各器官的整體移植量。

  • Here are the key highlights.

    以下是主要亮點。

  • For the third consecutive year, we grew the total OCS transplant volume. As of February 22, 2026, our internal company data and Yuno's database recorded the records showed that there were 5,139 total US OCS transplant performed in the full year 2025. Let me repeat this. As of February 22, 2026, our internal company and Yunus database records show that OCS was responsible for 5,139 transplants performed in the full year 2025, up from 3,735 US OCS transplants in 2024.

    我們連續第三年實現了OCS移植總量的成長。截至 2026 年 2 月 22 日,我們公司內部資料和 Yuno 的資料庫記錄顯示,2025 年全年美國共進行了 5,139 例 OCS 移植手術。讓我再說一次。截至 2026 年 2 月 22 日,我們公司內部和尤努斯資料庫記錄顯示,OCS 在 2025 年全年進行了 5,139 例移植手術,高於 2024 年美國 OCS 移植手術的 3,735 例。

  • The overall transplants represented approximately 26% of the total 19,833 US transplants for the year.

    這些移植手術約佔當年美國移植手術總數 19,833 例的 26%。

  • For heart, lung, and liver in 2025, and up from 20% of the 2024 US transplant volume for the same organs.

    2025 年,心臟、肺和肝臟的移植數量將比 2024 年美國同類器官移植數量的 20% 增加。

  • Importantly, for the third consecutive year, we saw growth in overall US liver and heart and lung transplant volumes. For the full year 2025, there were 19,833 liver, heart, and lung transplants, up from 18,894 in 2024.

    值得注意的是,美國肝臟、心臟和肺移植總量連續第三年成長。2025 年全年,肝臟、心臟和肺移植手術數量為 19,833 例,高於 2024 年的 18,894 例。

  • We strongly believe that the OCSNOP once again played a key role in driving overall liver and heart market growth due to the increased use of DCD and DVD donors in the US.

    我們堅信,由於美國 DCD 和 DVD 捐贈者的使用量增加,OCSNOP 再次在推動肝臟和心臟整體市場成長方面發揮了關鍵作用。

  • Since 2022, US national transplant volumes for liver, heart, and lung grew at a rate of 25%, including OCS NOP transplant volume.

    自 2022 年以來,美國肝臟、心臟和肺臟的全國移植量增加了 25%,其中包括 OCS NOP 移植量。

  • Without OCS volume, national volumes for the same organs would have declined by approximately 1% over the same period. Please allow me to repeat this.

    如果沒有 OCS 手術量,同期全國同類器官的手術量將下降約 1%。請允許我重複一遍。

  • US transplant volumes for liver, heart and lung grew up 25% with OCSNOP and would have declined by approximately 1% without OCSNOP case volume.

    OCSNOP 使美國的肝臟、心臟和肺移植數量增加了 25%,如果沒有 OCSNOP 的病例量,移植數量將下降約 1%。

  • Based on these facts, we believe that we are delivering on our vision of growing the overall US market.

    基於這些事實,我們相信我們正在實現擴大美國整體市場的願景。

  • Said differently, we are expanding the overall market, not just taking share.

    換句話說,我們正在擴大整體市場,而不僅僅是搶佔市場份額。

  • Now let me discuss our clinical adoption per organ. For liver, in 2025, OCS liver transplant represented 4,197 transplants, or 36% of the overall liver transplant volume in the United States. That is up from 26% in the same period in 2024.

    現在讓我來談談我們按器官進行的臨床應用。2025 年,OCS 肝臟移植手術數量為 4,197 例,占美國肝臟移植手術總量的 36%。這一比例高於 2024 年同期的 26%。

  • For heart, OCS transplant represented 854 cases, or approximately 18% of the overall heart transplant volume, and modestly up from the 17%, seen in 2024.

    心臟方面,OCS 移植病例為 854 例,約佔心臟移植總量的 18%,比 2024 年的 17% 略有上升。

  • For lung, the numbers are small. OCS lung transplants represented only 88 cases, or approximately 2%. These are very small numbers, and we will discuss below how we are planning to address this particular topic.

    肺部病例較少。OCS 肺移植僅佔 88 例,約佔 2%。這些數字非常小,我們將在下面討論我們計劃如何處理這個特定問題。

  • These results underscore the significant remaining green field potential for OCSNOP cases across all three organs.

    這些結果凸顯了 OCSNOP 病例在所有三個器官中仍具有巨大的未開發潛力。

  • Specifically, we are focused on the enhanced heart program to drive increased use in heart transplantation across donor types.

    具體來說,我們專注於加強心臟移植項目,以推動各種類型供體心臟在心臟移植中的應用。

  • Finally, our de novo lung clinical program will focus on reinvigorating the OCS lung market segment in the US while driving much needed expansion of the utilization rates for donor lungs. Both programs have been cleared by FDA and are in various stages of trial activation. And enrollment in the US. We're looking forward to reporting the progress of these two crucial programs at the upcoming ISHLT in late April.

    最後,我們的全新肺部臨床計畫將著重振美國 OCS 肺市場,同時推動急需的供體肺利用率的擴大。這兩個項目都已獲得FDA批准,目前正處於不同的試驗啟動階段。以及在美國的入學。我們期待在四月下旬即將舉行的國際心肺技術學會 (ISHLT) 會議上報告這兩個關鍵項目的進展。

  • Now let me move on to discuss our 2026 plans and guidance.

    現在讓我來談談我們2026年的計畫和指導方針。

  • As we stated before, we're excited for 2026 as we believe it will represent another critical and transformative year for Transmedics business, given our focus on few wide ranging and far reaching catalysts for near, mid, and long-term growth for our business.

    正如我們之前所說,我們對 2026 年充滿期待,因為我們相信,鑑於我們專注於少數幾個影響深遠、作用廣泛的催化劑,這將代表 Transmedics 業務的又一個關鍵和變革之年,以實現我們業務的近期、中期和長期增長。

  • Let me share with you a summary overview of all the growth catalysts we are focused on in 2026.

    讓我向大家簡要概述我們在 2026 年重點關注的所有成長催化劑。

  • First, OCS and enhanced heart program simply stated, Part A of this program is designed to move cardiac transplantation beyond preservation and into functional enhancement of donor hearts. Importantly, it was designed to significantly expand the time and distance limitations currently imposed on the 4 hour DVD heart transplants preserved using cold static storage.

    首先,OCS 和增強心臟計劃簡單來說,該計劃的 A 部分旨在將心臟移植從保存轉向供體心臟的功能增強。重要的是,它旨在大幅擴展目前對使用冷靜態儲存保存的 4 小時 DVD 心臟移植施加的時間和距離限制。

  • Initial feedback is promising, but we are still early in the process.

    初步回饋令人鼓舞,但我們仍處於早期階段。

  • Now, let's talk about Part B.

    現在,我們來談談B部分。

  • Part B of this program is designed to allow OCS to gain a potential new clinical indication in DVD heart transplant segment that are sub 4 hours preservation by demonstrating superiority of outcomes in a head to head comparison to current cold static storage modalities.

    該計劃的 B 部分旨在透過與目前冷靜態保存方式進行直接比較,證明其結果優越性,從而使 OCS 能夠在 DVD 心臟移植領域獲得潛在的新臨床適應症,該領域保存時間小於 4 小時。

  • Progress in Part B has been slightly impacted by a competitive dynamic as it relates to the cold storage arm of the trial.

    B 部分的進展受到了與試驗冷藏部分相關的競爭動態的輕微影響。

  • Specifically, there's a hesitation amongst competition to a head to head comparison between OCS and their static cold storage modality.

    具體來說,競爭對手們對於OCS與其靜態冷藏模式進行直接比較持謹慎態度。

  • We are confident in our ability to overcome this competitive dynamic that we somewhat expected. Importantly, we are committed to conducting this important part of our heart program with the highest level clinical evidence and robust protocol and randomization scheme.

    我們有信心克服這種我們預料之中的競爭局面。重要的是,我們致力於以最高等級的臨床證據和可靠的方案及隨機化方案來進行我們心臟計畫的這一重要部分。

  • If successful, One or both parts combined could dramatically increase the use of OCS heart in the US and should have a huge impact on our transplant volume and top top-line revenue growth.

    如果成功,其中一項或兩項結合起來,可能會大幅增加 OCS 心臟在美國的使用,並對我們的移植數量和最高收入成長產生巨大影響。

  • Next is OCS de novo lung program.

    接下來是OCS新興肺部疾病治療計畫。

  • As I've stated before, in our humble view, this is the last real chance for the lung transplant community to experience the benefits of machine perfusion and integrated NOP services in lung transplantation in the US.

    正如我之前所說,在我們看來,這是肺移植界在美國體驗到機器灌注和綜合 NOP 服務帶來的益處的最後真正機會。

  • If successful, this program would resurrect a sleeping giant of lung transplant market and would would add significant lung clinical adoption and top-line revenue growth for Transmedics.

    如果成功,該計劃將重振肺移植市場這個沉睡的巨頭,並為 Transmedics 帶來顯著的肺移植臨床應用和營收成長。

  • Next is bringing the NOP model to Europe and the rest of the world.

    接下來是將 NOP 模型推廣到歐洲和世界其他地區。

  • This program is actively launching in Italy.

    該項目正在義大利積極推進。

  • And few other European countries have expressed strong interest in exploring the NOP model in their local geography.

    很少有其他歐洲國家對在其本地地理範圍內探索 NOP 模型表現出濃厚的興趣。

  • This program has the potential to significantly grow our OCS market adoption in Europe.

    該項目有望顯著提升我們在歐洲的OCS市場佔有率。

  • Expanding our commercial activities in Europe has the potential to nearly double our transplant total addressable market for Transmedics.

    在歐洲擴大商業活動有可能使我們 Transmedics 的移植市場總目標市場規模翻倍。

  • We are actively engaged in building our European transplant, air and ground logistics network while also expanding our European clinical support infrastructure.

    我們正積極致力於建立歐洲移植、空運和陸運物流網絡,同時也擴大歐洲臨床支援基礎設施。

  • Next is the OCS kidney program.

    接下來是OCS腎臟計畫。

  • This represents our next frontier and will be the first organ to launch on our OCS Gen 3.0 technology platform.

    這代表了我們的下一個前沿領域,並將是第一個在我們 OCS Gen 3.0 技術平台上推出的器官。

  • OCSG 3.0 will have a completely redesigned technology and profusion systems that is smaller, lighter, and with a much lower part count. Importantly, it's designed for automated assembly and was designed to operate with a high degree of reliability.

    OCSG 3.0 將採用完全重新設計的技術和灌注系統,使其體積更小、重量更輕,零件數量也更少。重要的是,它是為自動化組裝而設計的,並且在設計時就考慮到了高度的可靠性。

  • There are currently more than 20,000 deceased kidney transplants in the US annually.

    目前美國每年有超過2萬例腎臟移植手術(病人為已故腎源)。

  • And an additional 80 to 9,000 kidneys that are discarded annually in the US for only prolonged ischemic times.

    在美國,每年還有 80 至 9,000 個腎臟因缺血時間過長而被丟棄。

  • To our knowledge, the OCS kidney system will be the first and only warm perfusion oxygenated kidney platform for kidney transplantation used from the donor to the recipient.

    據我們所知,OCS 腎臟系統將是第一個也是唯一一個用於腎臟移植的溫灌注氧合腎臟平台,用於將腎臟從捐贈者移植到受體。

  • Currently, the development program is running in full gear throughout 2026 to get the platform ready for FDA trial by early 2027.

    目前,該開發計畫正在 2026 年全面展開,目標是在 2027 年初使該平台做好接受 FDA 試驗的準備。

  • Next is OCSG 3.0 for liver, heart, and lung systems. This program is running in parallel to the kidney program to upgrade our current liver, heart, and lung system and help grow our clinical adoption rates and scale our operations.

    接下來是用於肝臟、心臟和肺部系統的 OCSG 3.0。該計畫與腎臟計畫並行,旨在升級我們現有的肝臟、心臟和肺系統,並幫助我們提高臨床應用率,擴大營運規模。

  • Finally, we are exploring the potential to capitalize on the US transplant modernization initiatives driven by HRSA, CMS, and US Congress.

    最後,我們正在探索如何利用美國衛生資源和服務管理局 (HRSA)、醫療保險和醫療補助服務中心 (CMS) 以及美國國會推動的移植現代化計劃。

  • Specifically, we are exploring if Transmedics can be a more integrated contributor to the national transplant ecosystem in the US. The goal is to maximize donor organ utilization for transplantation and continue to save more American lives and save significant healthcare dollars.

    具體來說,我們正在探索 Transmedics 能否成為美國國家移植生態系統中更緊密的貢獻者。目標是最大限度地利用捐贈器官進行移植,從而繼續拯救更多美國人的生命,並節省大量醫療保健費用。

  • As you can see, these are significant potential short, mid, and long-term catalysts for our business, and we are laser focused on ensuring successful execution of these initiatives throughout 2026. That being said, we're also cognizant of a few operational challenges that could influence the pace and timing of these initiatives.

    如您所見,這些是我們業務在短期、中期和長期內具有重大潛在催化作用的因素,我們將全力以赴確保這些舉措在 2026 年取得成功。儘管如此,我們也意識到一些營運方面的挑戰可能會影響這些措施的進度和時間安排。

  • First, as stated, we are still building.

    首先,正如前面所說,我們仍在建設中。

  • Out our logistics infrastructure in Europe which could moderate the initial pace of our EU NOP launch as we ensure we have the right foundation in place.

    我們在歐洲的物流基礎設施可能會減緩我們歐盟 NOP 啟動的初期速度,因為我們需要確保我們有正確的基礎。

  • Second, timing of the full de novo trial accrual will depend on how long and how the lung transplant market adopts machine profusion and NOP, which remains to be proven.

    其次,全面進行新發試驗的時間將取決於肺移植市場採用機器灌注和 NOP 的時間長短和方式,這還有待證明。

  • Third, timing of enhanced Part B completion will be influenced by some of the inertia created by competitive dynamics for the cold storage arm in the in the marketplace.

    第三,增強型 B 部分的完成時間將受到市場中冷藏業務競爭動態所產生的一些慣性的影響。

  • Fourth, the very common and now I hope well understood annual phenomena of potential Q3 seasonality in US transplant market that temporarily slows down transplant activities.

    第四,美國移植市場第三季季節性波動是一個非常普遍的現象,我希望現在大家都能理解,這種波動會暫時減緩移植活動。

  • And finally, ramping our infrastructure and clinical staffing to meet the growing demand for OCSNOP will be critical to achieve our full growth potential in 2026.

    最後,為了滿足 OCSNOP 日益增長的需求,我們需要加強基礎設施建設和臨床人員配備,這對於我們在 2026 年充分發揮成長潛力至關重要。

  • With all this in mind, we are setting our revenue guidance for full year 2026 between $727million and $757 million representing approximately 20% to 25% growth over full year 2025. With that, let me turn the call to Gerardo to cover the detailed financial results for the quarter.

    考慮到所有這些因素,我們將 2026 年全年的收入預期設定在 7.27 億美元至 7.57 億美元之間,比 2025 年全年增長約 20% 至 25%。接下來,我將把電話交給傑拉爾多,讓他詳細介紹本季的財務表現。

  • Gerardo Hernandez Omana - Chief Financial Officer

    Gerardo Hernandez Omana - Chief Financial Officer

  • Thank you, buddy.

    謝謝你,兄弟。

  • Good afternoon, everybody. I am pleased to share Transmedics fourth quarter 2025 results.

    大家下午好。我很高興與大家分享 Transmedics 2025 年第四季業績。

  • Please note that a supplemental slide presentation with additional details is available in the investor section of our website.

    請注意,我們網站的投資者關係部分提供了包含更多詳細資訊的補充幻燈片簡報。

  • As well is highlighted, we sustained strong momentum through the fourth quarter, closing the year with solid performance following an expected seasonally softer third quarter in US transplant activity.

    如前文所述,我們在第四季度保持了強勁的成長勢頭,在經歷了預期中的季節性疲軟的第三季度美國移植活動後,最終以穩健的業績結束了這一年。

  • As discussed in our Q3 call, our rapid growth in prior years often masked the natural seasonality in the US transplant activities. At our current scale, those dynamics are more visible. However, as we have seen, these fluctuations tend to normalize over the full year.

    正如我們在第三季電話會議中所討論的,前幾年的快速成長往往掩蓋了美國移植活動的自然季節性。以我們目前的規模來看,這些動態更加明顯。然而,正如我們所看到的,這些波動往往會在一年內趨於正常。

  • Total revenue for the quarter was approximately $161 million.

    本季總收入約1.61億美元。

  • US transplant revenue was approximately $155 million up 33% year over year and 11% sequentially.

    我們移植收入約 1.55 億美元,年增 33%,季增 11%。

  • By organ, liver contribute with $127 million, heart $26 million, and lung $2 million.

    按器官劃分,肝臟貢獻了 1.27 億美元,心臟貢獻了 2600 萬美元,肺部貢獻了 200 萬美元。

  • International revenue was $4.8 million, up 24% year over year and 33% sequentially. Revenue by organ was $3.9 million in heart, $0.2 million in lung, and $0.7 million in liver.

    國際營收為 480 萬美元,年增 24%,季增 33%。以器官劃分的收入分別為:心臟 390 萬美元,肺 20 萬美元,肝臟 70 萬美元。

  • Growth was primarily driven by liver and heart.

    增長主要由肝臟和心臟驅動。

  • While we continue to make progress in our international expansion plans, the business remains at an early stage, and quarterly variability is expected due to reimbursement and market dynamics.

    雖然我們的國際擴張計劃不斷取得進展,但該業務仍處於早期階段,由於報銷和市場動態的影響,預計季度業績將有波動。

  • Product revenue for the fourth quarter was $100 million up 34% year over year and 15% sequentially, reflecting continued momentum across both liver and heart programs.

    第四季產品營收為 1 億美元,年增 34%,較上季成長 15%,反映出肝臟和心臟計畫持續維持成長動能。

  • Service revenue for the fourth quarter was $60 million up 29% year over year and 8% sequentially. The primary driver of growth was logistics revenue, which increased 32% year over year and 5% sequentially, reflecting continued expansion and strong utilization of our aviation fleet compared to 2024.

    第四季服務收入為 6,000 萬美元,年增 29%,季增 8%。成長的主要驅動力是物流收入,年成長 32%,季增 5%,反映出與 2024 年相比,我們的航空機隊持續擴張和強勁利用率。

  • Together these results reflect strong organ utilization, continued OCS adoption, and increasing leverage of our integrated logistics platform. Total gross margin for the quarter was approximately 58%, down 110 basis points year over year and 70 basis points sequentially.

    這些結果共同反映了器官的高效利用、OCS 的持續採用以及我們一體化物流平台的日益發揮作用。本季總毛利率約 58%,較去年同期下降 110 個基點,較上季下降 70 個基點。

  • The year over year decline primarily reflects higher clinical service costs associated with expansion of our NOP program, increased logistic discounts, and higher freight expenses.

    與去年相比,下降主要反映了由於 NOP 項目的擴展而導致的臨床服務成本增加、物流折扣增加以及貨運費用增加。

  • The sequential decrease was mainly driven by inventory-related charges associated with our year-end inventory procedures and higher freight costs from expedited shipments to replenish our hubs.

    環比下降的主要原因是與年末庫存盤點程序相關的庫存費用,以及為補充樞紐庫存而加急發貨導致的較高運費。

  • Total operating expenses for the fourth quarter of 2025 were $72 million up 14% year over year and 18% sequentially.

    2025 年第四季總營運支出為 7,200 萬美元,年增 14%,季增 18%。

  • The year over year growth was mainly driven by increased R&D investment to advance our innovation pipeline and expand product development capabilities, including targeted additions to our technical and development teams.

    與上年相比,成長主要得益於研發投入的增加,以推進我們的創新產品線並擴大產品開發能力,包括有針對性地擴充我們的技術和開發團隊。

  • SG&A growth reflected continued IT infrastructure expansion, strategic growth initiatives, and selective head count investments to support scale.

    銷售、一般及行政費用成長反映了 IT 基礎設施的持續擴張、策略性成長舉措以及為支持規模擴張而進行的有選擇的員工人數投資。

  • Sequentially, the increase was largely driven by higher R&D investment related to development and testing activities, as well as incremental SDNL investment supporting growth and expansion initiatives.

    從順序上看,成長主要由與開發和測試活動相關的研發投資增加以及支援成長和擴張計畫的 SDNL 增量投資所驅動。

  • Operating income for the quarter was $21million, 146% year over year and down 9% sequentially.

    本季營業收入為 2,100 萬美元,年增 146%,季減 9%。

  • The sequential decrease was primarily driven by higher operating expenses associated with increased investment during the quarter.

    環比下降的主要原因是本季投資增加導致營運費用上升。

  • Operating margin expanded to 13% compared to 7% in the fourth quarter of 2024.

    營業利潤率從 2024 年第四季的 7% 成長至 13%。

  • Net income for the fourth quarter was $105 million a significant increase both year over year and sequentially. Net profit included an income tax benefit of $83.8 million compared to an income tax provision of $0.1 million in 2024, mainly related to the release of the evaluation allowance.

    第四季淨利為 1.05 億美元,與去年同期及環比均有顯著成長。淨利潤包括 8,380 萬美元的所得稅收益,而 2024 年的所得稅準備金為 10 萬美元,這主要與評估準備金的釋放有關。

  • The release of the valuation allowance on our deferred tax assets is not merely an accounting adjustment but a strong indication of our confidence in the sustainability of our long-term profitability grounded in continued growth and scalability.

    釋放遞延所得稅資產的估值準備金不僅是一項會計調整,更是我們對基於持續成長和規模化能力的長期獲利能力可持續性的有力體現。

  • This decision followed a thorough and rigorous evaluation of the applicable accounting and tax standards.

    這項決定是在對適用的會計和稅務準則進行全面、嚴格的評估之後做出的。

  • Earnings per share were $3.08 and diluted earnings per share were $2.62 for the fourth quarter of 2025.

    2025 年第四季每股收益為 3.08 美元,稀釋後每股收益為 2.62 美元。

  • We ended the year with $488 million in cash, of $22 million from September 30th of 2025, driven by strong operating cash generation and continued discipline working capital management.

    截至年底,我們擁有 4.88 億美元的現金,其中 2,200 萬美元將於 2025 年 9 月 30 日到期,這得益於強勁的經營現金流和持續嚴格的營運資本管理。

  • Overall, our fourth quarter performance reflects another quarter of strong execution, operational efficiency, and continued advancement across for clinical programs.

    整體而言,我們第四季的業績反映了我們在臨床專案方面又一個季度強勁的執行力、營運效率和持續進步。

  • As we operate at greater scale, the cosmetics team continues to demonstrate focus and discipline, investing in growth while maintaining strong financial and operational performance.

    隨著我們業務規模的擴大,化妝品團隊繼續展現出專注和自律,在保持強勁的財務和營運表現的同時,投資成長。

  • Now, let me summarize our full year 2025 results.

    現在,讓我總結一下我們2025年全年的業績。

  • Full year revenue reached approximately $605 million, representing 37% growth over 2024. Growth was led by liver, which grew almost 49% and continued strength in heart at almost 15%. Lung revenue was lower compared to 2024.

    全年營收達約 6.05 億美元,比 2024 年成長 37%。肝臟引領了成長,成長了近 49%,心臟也保持了強勁勢頭,成長了近 15%。與 2024 年相比,肺部收入有所下降。

  • US transplant revenue reached approximately $585 million, reflecting a 38.6% growth year over year.

    美國器官移植收入達到約 5.85 億美元,年增 38.6%。

  • Our international transplant revenue ended the year at $16.7 million, representing a 9.3% year over year growth primarily driven by liver and heart.

    本年度國際移植收入達 1,670 萬美元,年增 9.3%,主要得益於肝臟和心臟移植業務的成長。

  • Breaking it down by category, product revenue total $372 million while service revenue contributes with $233 million.

    按類別劃分,產品收入總計 3.72 億美元,服務收入貢獻 2.33 億美元。

  • Breaking it down by organ, Liver revenue reached $461 million, heart revenue reached $126 million and lung reached approximately $15 million.

    按器官細分,肝臟收入達 4.61 億美元,心臟收入達 1.26 億美元,肺臟收入約 1,500 萬美元。

  • School revenue for the year was $4 million.

    學校本年度收入為400萬美元。

  • Gross margin for the full year was 59.9%, up from 59.4% in 2024, reflecting logistics efficiencies and scale benefits. A portion of these gains was strategically shared with customers through logistic discounts enabled by our integrated network. Margins also reflect incremental costs related to our double shifting programs and higher expedited hub replenishment expenses.

    全年毛利率為 59.9%,高於 2024 年的 59.4%,反映了物流效率和規模效益。我們將部分收益透過我們整合的網路提供的物流折扣,以策略性的方式與客戶分享。利潤率也反映了與我們的雙班制計劃相關的增量成本以及更高的加急樞紐補貨費用。

  • Total operating expenses were $254 million up 13% year over year.

    總營運支出為 2.54 億美元,年增 13%。

  • The increase was primarily driven by a 23% increase in R&D investment reflecting continued investment in our innovation pipeline and product enhancements.

    此次成長主要得益於研發投入增加了 23%,這反映了我們對創新產品線和產品改進的持續投入。

  • SG&A grew almost 10% year over year, reflecting ongoing expansion of our IT infrastructure and investment in strategic growth initiatives.

    銷售、一般及行政費用年增近 10%,反映出我們 IT 基礎設施的持續擴張以及對策略性成長計畫的投資。

  • Operating margin expanded from 8.5% in 2024 to 18% in 2025, a significant achievement in a year where gross margin improved only modestly.

    2024 年的營業利潤率為 8.5%,2025 年則成長至 18%,在毛利率僅略有增加的一年裡,這是一個顯著的成就。

  • This performance demonstrates that the primary driver of margin expansion in our model is operating leverage as revenue scale supported by a strong discipline to cost management.

    這項業績表明,我們模型中利潤率擴張的主要驅動力是營運槓桿,即收入規模的擴大,而這又得益於嚴格的成本管理。

  • Net profit for the year was $490 million compared to approximately $36 million in 2024.

    本年度淨利為 4.9 億美元,而 2024 年約為 3,600 萬美元。

  • Results benefit from strong operating performance as well as the previously mentioned one-time income tax benefits recognized during the fourth quarter related to the deferred tax assets.

    業績受益於強勁的經營表現,以及前面提到的第四季度確認的與遞延所得稅資產相關的一次性所得稅優惠。

  • This performance positions us well as we enter 2026 with continued growth momentum and a strong financial foundation.

    這一業績使我們在進入 2026 年時處於有利地位,我們將保持持續成長勢頭並擁有強大的財務基礎。

  • Earnings per share was $5.60 and diluted earnings per share was $4.87.

    每股收益為 5.60 美元,稀釋後每股收益為 4.87 美元。

  • Now turning to our total revenue guidance for 2026, we anticipate revenue growth of 20% to 25% over the full year of 2025, which translates to a full year revenue range of approximately $727 million to $757 million. Growth is expected to be driven primarily by increased (oil) utilization, continued OCS adoption, and expansion of health service revenue.

    現在來看看我們對 2026 年的總營收預期,我們預計 2025 年全年營收將成長 20% 至 25%,這意味著全年營收範圍約為 7.27 億美元至 7.57 億美元。預計成長主要由石油利用率提高、OCS 持續普及以及醫療服務收入擴大所驅動。

  • In 2026, we expect similar seasonal dynamics in the US trans activity consistent with prior years.

    預計 2026 年美國跨大西洋貿易活動的季節性動態將與往年保持一致。

  • In terms of gross margin, we expect overall margins to remain around 50% over the long-term.

    就毛利率而言,我們預計長期來看整體毛利率將維持在 50% 左右。

  • This outlook reflects the fact of influencing both product and service margins beyond M alone.

    這種觀點反映了這樣一個事實:除了 M 之外,產品和服務利潤率也會受到影響。

  • As we expand internationally and continue investing ahead of growth, we may experience some near term pressure. However, we expect these impacts to normalize as volumes scale across markets.

    隨著我們向國際市場擴張,並持續進行成長前的投資,我們可能會面臨一些短期壓力。然而,我們預期隨著各市場交易量的擴大,這些影響將逐漸恢復正常。

  • In terms of capital allocation, our focus remains on driving long-term value. We are concentrating our investment in 3 key areas.

    在資本配置方面,我們的重點仍是創造長期價值。我們將投資重點放在以下三個關鍵領域。

  • First, fueling growth through through continued R&D investments, strengthening our MOP network and targeting expansion into selected international markets.

    首先,透過持續的研發投入、加強我們的MOP網路以及瞄準特定國際市場來推動成長。

  • Second, building a stronger foundation by implementing systems that simplify and optimize processes across the business, improving efficiency as we grow.

    其次,透過實施簡化和優化整個業務流程的系統,建立更強大的基礎,並隨著我們的發展提高效率。

  • And third, enhancing our infrastructure and strategic optionality, including our planned move to a new global headquarters to accommodate growth, ongoing upgrades, to expand our manufacturing and product development capabilities, and our continued evaluation of strategic opportunities that could further strengthen our platform for the future.

    第三,我們將加強基礎設施和策略選擇權,包括計劃搬遷到新的全球總部以適應成長,持續升級以擴大我們的製造和產品開發能力,並持續評估可能進一步加強我們未來平台的策略機會。

  • Collectively, these initiatives are preparing cosmetics for its next stage of expansion as we move beyond the 10,000 transplant milestones.

    總而言之,隨著我們突破 10,000 例移植里程碑,這些舉措正在為化妝品行業的下一階段擴張做好準備。

  • We continue to make progress on our double shifting pilot program to improve fleet utilization and expect to see early results in the first half of 2026.

    我們繼續推進雙班制試點項目,以提高車隊利用率,並預計在 2026 年上半年看到初步成果。

  • These insights will help us determine the right trade size and utilization model to maximize capital efficiency.

    這些見解將幫助我們確定合適的交易規模和利用模式,以最大限度地提高資本效率。

  • We achieved our goal of owning 22 jets by the end of 2025.

    我們實現了 2025 年底擁有 22 架噴射機的目標。

  • While there are no current plans to increase the fleet in 2026, we remain open to acquiring additional aircraft when the right conditions are in place, whether to enhance US capacity or to support international expansion.

    雖然目前沒有在 2026 年增加機隊的計劃,但我們仍然願意在合適的條件下購買更多飛機,無論是為了增強美國本土的運力還是為了支持國際擴張。

  • In 2026, we plan to meaningfully increase investment and with particular focus on advancing our clinical programs, completing the final development phase of our OCS kidney program, and continuing development of our next generation OCS platform.

    2026 年,我們計劃大幅增加投資,尤其註重推進臨床項目,完成 OCS 腎臟計畫的最後開發階段,並繼續開發下一代 OCS 平台。

  • It is important to note that approximately 50% of the incremental investment is transitory in nature, and as these initiatives are completed, expense levels should normalize, allowing us to capture additional operating levers over time.

    值得注意的是,新增投資中約有 50% 是暫時性的,隨著這些措施的完成,支出水準應該會恢復正常,使我們能夠隨著時間的推移獲得更多的營運槓桿。

  • Based on the current revenue guidance for 2026, we expect operating margins to be up to approximately 250 basis points below 2025 full year levels, primarily reflecting the timing and scale of these investments.

    根據 2026 年目前的營收預期,我們預計營業利潤率將比 2025 年全年水準低約 250 個基點,這主要反映了這些投資的時機和規模。

  • As investment levels normalize and the business continues to scale, we will expect operating margins to resume expansion.

    隨著投資水準恢復正常,業務規模不斷擴大,我們預期營業利潤率將恢復成長。

  • We continue to expect operating margins to approach 30% by 2028.

    我們仍預計到 2028 年營業利潤率將接近 30%。

  • As shared in previous quarters, we may see some fluctuations as we expand international and invest ahead of growth.

    正如前幾季所宣布的,隨著我們拓展國際市場並提前進行成長投資,我們可能會看到一些波動。

  • However, we remain confident in the long-term direction and scalability of our model.

    然而,我們對我們模型的長期發展方向和可擴展性仍然充滿信心。

  • As we look ahead, we see meaningful growth opportunities from multiple sources beyond continued organ utilization and OCS adoption, including the expected impact of our clinical programs, advancement OCS kidney program, and ongoing international expansion efforts. Together, these initiatives expand our addressable markets and reinforce the long-term growth potential of our platform.

    展望未來,除了器官的持續利用和 OCS 的採用之外,我們還看到了來自多個方面的有意義的成長機會,包括我們臨床計畫的預期影響、OCS 腎臟計畫的推進以及正在進行的國際擴張努力。這些舉措共同擴大了我們的目標市場,並增強了我們平台的長期成長潛力。

  • With a proven track record of delivering on what we set out to do, we are well positioned to continue creating long-term value while expanding access to transplantation and giving more patients a second chance at life.

    憑藉著以往實現既定目標的良好記錄,我們有能力繼續創造長期價值,同時擴大移植手術的覆蓋範圍,讓更多患者獲得第二次生命的機會。

  • And with that, I'll turn the call over to Waleed for closing remarks.

    接下來,我將把電話交給瓦利德,請他作總結發言。

  • Waleed Hassanein - President and Chief Executive Officer

    Waleed Hassanein - President and Chief Executive Officer

  • Thank you so much, Gerardo.

    非常感謝你,傑拉爾多。

  • Overall, we're very proud of our 2025 results as we delivered 37% year over year growth and achieve positive cash flow from operating activities.

    總體而言,我們對 2025 年的業績感到非常自豪,因為我們實現了 37% 的同比增長,並且經營活動產生了正現金流。

  • We did this while investing in our pipeline and continuing to build our infrastructure to capitalize on our highly differentiated OCS technology and service offering.

    我們一邊投資於我們的管道,一邊繼續建造我們的基礎設施,以充分利用我們高度差異化的OCS技術和服務產品。

  • We are now laser focused on executing in our initiatives in the potentially transformative 2026 year and are excited about what's ahead.

    我們現在正全力以赴地執行各項計劃,迎接可能具有變革意義的 2026 年,並對未來充滿期待。

  • In conclusion, we're humbled and proud of the significant life saving impact of our OCS technology, NOP service, and dedicated team and remain committed to our mission of expanding access and improving clinical outcomes to patients in need of organ transplantation worldwide.

    總之,我們對 OCS 技術、NOP 服務和敬業的團隊所取得的重大救命成果感到無比自豪和榮幸,並將繼續致力於擴大全球需要器官移植的患者獲得器官移植的機會,並改善其臨床療效。

  • With that, I will now turn the call to the operator for Q&A. Operator.

    接下來,我將把電話轉交給接線生進行問答環節。操作員。

  • Operator

    Operator

  • (Operator Instructions)

    (操作說明)

  • Allen Gong from JPMorgan Chase and Company.

    來自摩根大通公司的艾倫龔。

  • Allen Gong - Analyst

    Allen Gong - Analyst

  • Thanks for the question and congrats on a really good quarter to end the year. I guess my question is going to be on guidance if I'm limiting it to one, you're guiding a step above the street, even after factoring in to be in the quarter when we think about the midpoint of the range, you clearly have a lot of moving parts next year between underlying growth and liver and heart, and the enrollment of the clinical trials and you also have Italy in the back half. So, when it comes to, those three dynamics, can you talk, broadly about your expectations for those and how that factors into your guidance philosophy?

    感謝你的提問,也恭喜你們以一個非常出色的季度結束了這一年。我想問的問題是關於業績指引,如果只能問一個,你們的指引比華爾街的預期高出一個檔次,即使考慮到這是季度業績指引的中點,明年你們顯然有很多不確定因素,包括基礎增長、肝臟和心臟手術、臨床試驗的招募情況,以及下半年意大利的業績。那麼,關於這三個方面,您能否大致談談您對它們的期望,以及這些期望如何融入您的指導理念?

  • Waleed Hassanein - President and Chief Executive Officer

    Waleed Hassanein - President and Chief Executive Officer

  • Thanks, Allen. As always, we take guidance very seriously at Transmedics, and, we have huge opportunities ahead of us as we outlined, Gerardo and myself, but also we have, a few challenges and, a few moving dynamics. So, in our guidance, we factored in all of the above and issued what we believe is a realistic guidance that would enable us to execute and let the execution and performance, dictate what do we do, or if we need to revisit the guidance. So we feel confident in the guidance that we are putting forth here, and it as it bakes in all the uncertainties, all the opportunities and uncertainties in front of us. So, again, we would go and execute and we'll let the execution and the results and the performance dictate, if we need to revisit the guidance as we move forward throughout the year.

    謝謝你,艾倫。與以往一樣,Transmedics 非常重視指導,正如我和 Gerardo 所概述的那樣,我們面前有很多機遇,但同時也有一些挑戰和一些不斷變化的情況。因此,在我們的指導意見中,我們考慮了以上所有因素,並發布了我們認為切實可行的指導意見,使我們能夠執行,並讓執行情況和績效來決定我們做什麼,或者是否需要重新審視該指導意見。因此,我們對我們在此提出的指導充滿信心,因為它包含了我們面前的所有不確定性、機會和不確定性。所以,我們再次強調,我們會執行計劃,然後根據執行情況、結果和業績來決定是否需要在今年繼續推進計劃並重新審視指導方針。

  • Operator

    Operator

  • Josh Jennings from TD Cowen

    TD Cowen公司的Josh Jennings

  • Josh Jennings - Analyst

    Josh Jennings - Analyst

  • Hi, good afternoon. Thanks, and, great to see this strong start to the end of the year. Appreciate the breakout of the catalyst late in 2026. I was hoping to ask a question on OCS liver. Well, you, you've talked publicly about, a registry, publication coming up in the near term that it could be a huge catalyst for liver adoption. I know you don't, can't front run the results here, but I was wondering one. Just, I mean, could we see some cost effectiveness data published in the near term, and just thinking about that element of OCS Liver as new competition is coming into place and just are you seeing any competitive headwinds out there that are new in 2026 for the OCS Liver franchise?

    您好,下午好。謝謝,很高興看到年底有個如此強勁的開端。預計催化劑將在 2026 年底爆發。我原本想問一個關於OCS肝臟的問題。嗯,您曾公開談到,近期將有一個登記冊發布,這可能會成為肝臟移植普及的巨大催化劑。我知道你無法提前知道結果,但我還是想問一個問題。我的意思是,我們能否在近期內看到一些成本效益數據公佈?考慮到 OCS Liver 的這一方面,隨著新的競爭對手出現,您是否看到 OCS Liver 在 2026 年會面臨任何新的競爭阻力?

  • Thank you.

    謝謝。

  • Waleed Hassanein - President and Chief Executive Officer

    Waleed Hassanein - President and Chief Executive Officer

  • Thank you, Josh. I think, let me address that question in 3 pieces. The first piece is, there are, health, economic data and liver transplant that's already published, many of them, for the last 2 years, single center experience. So that's already in the print, but what's coming is really the unequivocal, drop the mic statistical superiority in the most important. Outcomes after liver transplantation, which would justify and support all the evidence that's been built in having more than 14 or 15 publications now already in print, out there. Those publications that are coming, they're aggregated of thousands of cases, they're coming out of our registry and. There're many of them are already, under review. I cannot comment when are they going to come out because obviously, I cannot, interfere with the review process, given that these are very high impact journals. The last piece, the comment about competition. Listen, we're very cognizant, of everything that moves in the field of organ transplant. We are not seeing competitive dynamic, impacting our ability to execute in 2026 and beyond, and I will leave it at that.

    謝謝你,喬許。我認為,讓我分成三個部分來回答這個問題。首先,已經有一些關於健康、經濟和肝臟移植的數據發表,其中許多數據來自過去兩年的單中心經驗。所以這一點已經寫進了報紙裡,但真正即將到來的,是無可爭議的、壓倒性的統計優勢,尤其是在最重要的方面。肝臟移植後的結果,將證明並支持目前已發表的 14 或 15 篇以上出版物所累積的所有證據。即將發表的那些文章,都是總結了數千個案例,它們來自我們的登記處。其中很多已經在審查中。我無法評論它們何時會發表,因為很明顯,我不能幹​​預審稿過程,畢竟這些都是影響力非常大的期刊。最後一部分是關於競爭的評論。聽著,我們非常關注器官移植領域的一切動態。我們目前沒有看到任何競爭動態會影響我們在 2026 年及以後的執行能力,我就說到這裡吧。

  • Next question operator, please.

    下一個問題,接線生。

  • Operator

    Operator

  • Bill Holvinni from Knaco Genuity.

    來自 Knaco Genuity 的 Bill Holvinni。

  • Unidentified Participant

    Unidentified Participant

  • Hi, it's Zachary. I'm from Bill.

    嗨,我是紮克瑞。我來自比爾。

  • Thank you for taking the question. Just a quick one on, can you provide more details on NOP Connect 2.0? I believe you talked about that in the last earnings call, saying it would provide you operational efficiencies. Can you talk about what you've seen early on so far? Thank You.

    感謝您回答這個問題。請問您能否提供更多關於 NOP Connect 2.0 的詳細資訊?我相信您在上次財報電話會議上談到過這一點,並說這將提高營運效率。可以談談目前為止你觀察到的早期情況嗎?謝謝。

  • Waleed Hassanein - President and Chief Executive Officer

    Waleed Hassanein - President and Chief Executive Officer

  • Thank you, Zach. We've seen a lot. We've seen it, it's now, it's the platform, I would say the vast majority of our cases are now coming through the NOP, 2.0, NOP Connect 2.0, and, we're seeing efficiency in the management, we're seeing efficiency in the billing. But again, these are early days, early quarters, we are, as we look forward, we see continuous improvement and expansion of our digital ecosystem. This is our, this is going to be our second legacy after the OCS. This digital ecosystem is now fully integrated, fully supporting significant portion of the national transplant volume in the US, and our commitment is to continue to support it, continue to expand it, to provide the best service for our customers, but the best and the broadest transparency about the status of the organ, the management of the organ, as well as the financial, billing around the Transmedics.

    謝謝你,扎克。我們已經見識很多了。我們已經看到了這一點,現在,這就是平台,我想說,我們絕大多數的案例現在都是透過 NOP 2.0 和 NOP Connect 2.0 處理的,而且,我們看到了管理效率的提高,我們也看到了計費效率的提高。但話說回來,現在還只是初期階段,賽季初期,展望未來,我們將看到我們的數位生態系統不斷改進和擴展。這是我們的,這將是我們繼軍官訓練學校之後的第二個重要遺產。這個數位生態系統現在已經完全整合,為美國大部分國家移植量提供了全面支持,我們承諾將繼續支持它,繼續擴展它,為我們的客戶提供最好的服務,以及關於器官狀態、器官管理以及Transmedics相關財務和計費方面最透明、最廣泛的信息。

  • So we, we're very encouraged by what we're seeing and we're going to continue to make strategic investments in the digital platform to continue to expand and efficientize our market adoption of OCS.

    因此,我們對目前所看到的情況感到非常鼓舞,我們將繼續對數位平台進行策略性投資,以繼續擴大和提高 OCS 的市場採用率。

  • Next question, please, operator.

    下一個問題,接線生。

  • Operator

    Operator

  • Suraj Kalia from Oppenheimer and Company.

    來自奧本海默公司的蘇拉傑·卡利亞。

  • Suraj Kalia - Analyst

    Suraj Kalia - Analyst

  • Hey Waleed, Gerardo, tamer, Nick, excellent quarter, can you hear me all right.

    嘿,瓦利德、傑拉爾多、塔默、尼克,精彩的四分之一,你們能聽清楚我說話嗎?

  • Waleed Hassanein - President and Chief Executive Officer

    Waleed Hassanein - President and Chief Executive Officer

  • Waleed? We can hear you loud and clear, Suraj.

    瓦利德?蘇拉傑,我們聽得很清楚。

  • Suraj Kalia - Analyst

    Suraj Kalia - Analyst

  • I'll just kind of quickly sneak into it seems like you guys gained about 400 beeps of liver share in Q4. Why was that? And Waleed, your comments about Part B of enhance.

    我快速插一句,你們似乎在第四季度獲得了大約 400 個肝臟份額。為什麼會這樣呢?瓦利德,你對增強部分的B有什麼評論?

  • Look, the numbers are suggesting you guys are going to exit FY26 with approximately 6,300 organs, but if I parlay your clinical trial commentary, it means like you're not expecting a lot of contribution.

    你看,數據顯示你們在 2026 財年結束時將擁有大約 6300 個器官,但如果我理解你們的臨床試驗評論,那就意味著你們似乎並不期望獲得很多貢獻。

  • Y'all must have put in some safeguards in place if paragonics or others threw a wrench in the control arm. Could you share some additional color on, how do you keep the ball moving in Part B, Gentlemen, congrats again.

    如果 Paragonics 或其他因素導致控制臂故障,你們肯定採取了一些安全措施。能否再詳細說說在 B 部分如何保持球的運轉?先生們,再次恭喜你們。

  • Waleed Hassanein - President and Chief Executive Officer

    Waleed Hassanein - President and Chief Executive Officer

  • Thank you, Suraj. The first, part of the question about the liver execution, listen, this is a testament, to the outcomes of the OCS liver. This is a testament, to our clinical leadership of the liver program. This is pure, Transmedics execution excellence, period, full stop. So, that answer part one. Part B.

    謝謝你,蘇拉傑。關於肝臟移植手術的問題的第一部分,聽著,這證明了 OCS 肝臟移植手術的成效。這證明了我們在肝臟疾病治療領域的臨床領導地位。這就是Transmedics卓越的執行力,毋庸置疑。好了,第一部分回答完畢。B 部分。

  • We were not, this is not our first rodeo. We're the, we're the company that have supported and completed the largest number of randomized and and single arm trials in the history of organ transplant. None of these cold static storage technologies have ever seen one FDA randomized or non-randomized trial, so we are, we were prepared and we somewhat expected this. We will execute Part B and it will be hopefully a significant success for Transmedics. It might take, a few extra months to navigate through this dynamic, but the bottom line is we're extremely confident in our strategy, in our design, in our technology, and it says a lot when the control arm is worried about randomizing against OCS.

    我們不是第一次遇到這種情況。我們是,我們是器官移植史上支持並完成最多隨機和單臂試驗的公司。這些冷靜態儲存技術都從未經過 FDA 的隨機或非隨機試驗,所以我們對此有所準備,以及多少預料到了這種情況。我們將執行B部分,希望它能為Transmedics帶來重大成功。可能需要額外幾個月的時間來應對這種動態變化,但最重要的是,我們對我們的策略、設計和技術都非常有信心,而當對照組擔心與 OCS 進行隨機分組時,這說明了許多問題。

  • So again, we're humbled by it. We're not letting that distract us from the task at hand, and as we committed, we are going to complete this study with the best protocol and the best randomization and with a control arm.

    所以,我們再次深感榮幸。我們不會讓這件事分散我們的注意力,也不會因為這件事而分心。正如我們所承諾的,我們將採用最佳方案、最佳隨機化方法以及對照組來完成這項研究。

  • Next question please operator.

    操作員,請問下一個問題

  • Operator

    Operator

  • Ryan Daniels from William Blair.

    來自威廉布萊爾的瑞安丹尼爾斯。

  • Ryan Daniels - Analyst

    Ryan Daniels - Analyst

  • Hello, this is Matthew Marulla on for Ryan.

    大家好,我是馬修·馬魯拉,替我替瑞恩報道。

  • Thank you for taking the questions and congrats on the quarter. And I kinda want to piggyback on that question, but I want to focus on the feedback you have received regarding the heart clinical trials. Given that you have already mentioned doing a handful of heart transplants for the trial, and I know it is still early in the process and ongoing. But I'm curious to hear what transplant surgeons feedback has been on the trials as they progress, and I kind of believe you previously mentioned and meeting all expectations. I'm curious how that has trended. And is there anything in particular transplant surgeons have called out regarding the device?

    感謝您回答問題,並祝賀您本季取得佳績。我想藉這個問題再補充一點,但我更想關注您收到的關於心臟臨床試驗的回饋。鑑於您已經提到要進行一些心臟移植試驗,而且我知道這項試驗仍處於早期階段,仍在進行中。但我很想知道移植外科醫生對試驗進展的回饋,而且我有點相信你之前提到的,試驗達到了所有預期。我很想知道這方面的發展趨勢如何。移植外科醫生是否對該設​​備提出任何特別的批評意見?

  • And maybe express more interest in using the device more in the future.

    或許還會表現出對未來更頻繁地使用該設備的興趣。

  • Waleed Hassanein - President and Chief Executive Officer

    Waleed Hassanein - President and Chief Executive Officer

  • If I tell you, if I answer that, it's a great question, Matt, and I appreciate the question, but if I answer that question, I might as well, have seen the results. The trial is just early in the process. It's good feedback. It speaks to the value.

    如果我告訴你,如果我回答這個問題,這是一個很好的問題,馬特,我很感謝你的提問,但如果我回答了這個問題,那我可能就看不到結果了。審判目前還處於早期階段。這是很好的回饋。這體現了它的價值。

  • Of everything we're trying to execute, I would leave it at that, and I hope to have more meaningful, presentations by users of the technology, not by Transmedics at the ISHLT symposium.

    對於我們正在努力執行的所有事項,我就說到這裡吧。我希望在 ISHLT 研討會上,能夠有更多由技術使用者而非 Transmedics 帶來的有意義的演講。

  • Next question please.

    下一個問題。

  • Operator

    Operator

  • David Rescott from Baird.

    來自 Baird 的 David Rescott。

  • David Rescott - Analyst

    David Rescott - Analyst

  • Great, thanks for taking the question. Congrats on the results here. I wanted to ask, and been hopping around a bit, so, I'm not sure if it's been covered yet, but, you, the CMS's, proposal on some of the OPO changes, there's obviously. A lot of stuff going on just on the OPO front in general. So wondering if you could give us some updated thoughts on, the state of affairs just on the broader OPO environment and whether or not, there's any, benefit that you could see or if this is, building out some of the thoughts on the OCS service in general and how we should think about this potentially over the longer-term.

    太好了,謝謝你回答這個問題。恭喜你取得這樣的成績。我想問一下,也一直在四處詢問,所以我不確定這個問題是否已經被討論過了,但是,您、CMS 以及關於 OPO 一些變更的提案,顯然是這樣的。總的來說,OPO方面發生了很多事情。所以,我想知道您能否就更廣泛的 OPO 環境現狀,以及您是否看到了任何好處,或者能否就 OCS 服務總體上的一些想法,以及我們應該如何從長遠角度考慮這個問題,提供一些最新的看法。

  • Waleed Hassanein - President and Chief Executive Officer

    Waleed Hassanein - President and Chief Executive Officer

  • Thank you, David. All I could say is, organ transplant system in the United States is going through, really, significant transformation, hopefully to the positive. We are, supportive of the CMS language, proposed language. We're supportive of Senator Wyden's proposed bill to.

    謝謝你,大衛。我只能說,美國的器官移植系統正在經歷一場意義重大的變革,希望是朝著好的方向發展。我們支援 CMS 語言,即提議的語言。我們支持懷登參議員提出的法案。

  • Open up the historical closed transplant system to more competition, more transparency, more efficiency, more high standards of execution and metric, performance metrics, and we are going to try to play a. Ger role to support the vision, the growth and overall transplant in the United States, saving more American lives, delivering, cost-effective therapy to patients in need that's costing CMS, billions and billions of dollars, but also support existing OPOs in their missions. So we look at our role as, it's a win-win, opportunity for Transmedics to play a bigger role, but also support existing, OPOs.

    開放歷史上封閉的移植系統,引入更多競爭、更多透明度、更高效率、更高執行標準和指標、績效指標,我們將努力發揮作用。Ger 的角色是支持美國的願景、發展和整體移植,拯救更多美國人的生命,為有需要的患者提供經濟有效的治療,這每年花費 CMS 數十億美元,同時也支持現有的 OPO 完成其使命。因此,我們認為我們的角色是一個雙贏的機會,既能讓 Transmedics 發揮更大的作用,又能支持現有的器官獲取組織 (OPO)。

  • That's all I can comment on at the moment.

    目前我只能就此發表評論。

  • Next question, please.

    下一個問題。

  • Operator

    Operator

  • Daniel Markowitz from Evercore ISI.

    來自 Evercore ISI 的 Daniel Markowitz。

  • Daniel Markowitz - Analyst

    Daniel Markowitz - Analyst

  • Guys, congrats on the quarter and thanks for taking my question. I wanted to ask on the operating margin guide for 2026, it sounds like the gross margins may see some volatility, as you expand internationally. And then OpEx as a percent of sales is expected to increase as well to get to that 250 bits of contraction year on year, I guess. Can you give us the breakout of how much of the margin contraction is coming from some expansion dynamics that weren't really areas of investment yet in 2025, things like international expansion. Trial spend that are kind of I guess one time in nature and with so many exciting investment opportunities, what are you looking at that tells you that it'll make sense to get the business back to significant margin expansion in 2027 and 2028 as opposed to continuing to bring money into investments?

    各位,恭喜你們本季取得好成績,感謝你們回答我的問題。我想問一下關於 2026 年的營業利潤率預期,聽起來隨著你們的國際擴張,毛利率可能會出現一些波動。然後,營運支出佔銷售額的百分比預計也會增加,以達到同比下降 250 比特的目標。能否詳細說明一下,利潤率收縮有多少是由於一些擴張動態造成的,而這些擴張動態在 2025 年還不是真正的投資領域,例如國際擴張?試探性支出本質上屬於一次性支出,而且有這麼多令人興奮的投資機會,您認為在 2027 年和 2028 年讓企業恢復到顯著的利潤率擴張狀態,而不是繼續將資金投入投資,是明智之舉嗎?

  • Gerardo Hernandez Omana - Chief Financial Officer

    Gerardo Hernandez Omana - Chief Financial Officer

  • So the big drivers of, almost 50% of the incremental investment that we have in 2026 is driven by really three elements. One, it's the completion of our clinical programs and, OCS enhanced and, the novo.

    因此,到 2026 年,我們新增投資的近 50% 是由以下三個因素所驅動的。第一,是我們臨床計畫的完成,以及 OCS 的增強和 novo。

  • We have, the second part is the completion of our OCS kidney, development, and the third one is the continued development of our. OCS Next generation or 3.0 as we are calling it, recently.

    第二部分是完成我們的 OCS 腎臟開發,第三部分是我們繼續開發。OCS 下一代,或我們最近稱之為 3.0 版本。

  • Those three elements account for A little bit more than half of the incremental investment.

    這三項要素佔新增投資金額的一半多一點。

  • And those by by nature are transitory. So once we complete those elements, that's what gives me the confidence that Spain should normalize and then we we should be able to start capture and operating leverage as we continue to grow. I hope that answers the question.

    而這些本質上都是短暫的。所以一旦我們完成了這些要素,我就有信心西班牙會恢復正常,然後我們就能開始利用槓桿效應繼續成長。希望這能解答你的疑問。

  • Daniel Markowitz - Analyst

    Daniel Markowitz - Analyst

  • Very helpful, thank you.

    非常有用,謝謝。

  • Waleed Hassanein - President and Chief Executive Officer

    Waleed Hassanein - President and Chief Executive Officer

  • Next question, please.

    下一個問題。

  • Operator

    Operator

  • Mike Matson from Needham and Company.

    來自 Needham and Company 的 Mike Matson。

  • Mike Matson - Analyst

    Mike Matson - Analyst

  • Yeah, thanks for taking my question. So just wanted to get some clarification on your comments on the, Part B of the enhanced trial, around the competitive issue that you called out. So, I guess the comparators static cold storage. So does that, I guess I would have assumed that was just putting the organ on ice, but does that really mean. One of these, cooler type technologies that's out there, and then is the competitor sort of trying to prevent their product from being used or in the trial or being enrolled in this trial, is that the issue? I guess I don't completely understand what's happening there.

    好的,謝謝你回答我的問題。所以我想就您在強化試驗的 B 部分中提到的競爭問題,得到一些澄清。所以,我猜比較物件是靜態冷儲存。所以,我猜那隻是把器官暫時冰凍起來,但那真的代表什麼嗎?其中一種比較先進的技術,其競爭對手是否試圖阻止他們的產品被用於試驗或參與試驗,這是問題所在嗎?我好像不太明白那裡發生了什麼事。

  • Waleed Hassanein - President and Chief Executive Officer

    Waleed Hassanein - President and Chief Executive Officer

  • Yes.

    是的。

  • That's exactly what's happening. Not everybody is using ice, static, cold storage boxes using phase changing elements are being used, and, the makers of that, Styrofoam box is refusing to randomize their technology to ours.

    事實正是如此。並非所有人都使用冰塊,有些人使用採用相變元件的靜態冷藏箱,而生產這種冷藏箱的泡沫塑膠箱製造商拒絕將其技術隨機化以適應我們的技術。

  • Mike Matson - Analyst

    Mike Matson - Analyst

  • Okay, got it, and I mean I guess how do you plan to kind of work around that or address that?

    好的,明白了。我的意思是,你打算如何解決這個問題?

  • Waleed Hassanein - President and Chief Executive Officer

    Waleed Hassanein - President and Chief Executive Officer

  • Wait and see.

    拭目以待。

  • We had hoped that this won't be the case, but we are kind of somewhat expecting it. So we have a plan, to, bypass that and, at the end of the day, it's the transplant programs that need to, take control of the trial and, TransMedics will support them with the right control arm that would be acceptable to FDA.

    我們原本希望不會發生這種情況,但現在看來,這種情況似乎也在意料之中。所以我們有一個計劃來繞過這個程序,歸根結底,移植項目需要掌控試驗,TransMedics 將為他們提供 FDA 可以接受的合適的對照組。

  • Operator

    Operator

  • Chris Pasquale from Nephron.

    來自 Nephron 的 Chris Pasquale。

  • Chris Pasquale - Analyst

    Chris Pasquale - Analyst

  • Thanks. Well, you had a really nice quarter and liver, but heart and lung were both a little bit lower than we expected. Was there anything that you noticed in those segments of the business, around the end of the year? In particular, I'm wondering if the trials, which got going a little bit slower than expected, might have caused any disruption or if there were any other dynamics there that would, sort of explain the deceleration we saw.

    謝謝。嗯,你的牛腩和牛肝都很不錯,但是牛心和牛肺都比我們預期的要差一些。在年底之際,您是否注意到這些業務板塊有什麼變化?我特別想知道,試驗進展比預期稍慢,這是否可能造成了任何干擾,或者是否有其他因素可以解釋我們看到的減速現象。

  • Waleed Hassanein - President and Chief Executive Officer

    Waleed Hassanein - President and Chief Executive Officer

  • The lung, Chris, as thank you for the question. The lung, as it's a, surrounding area for us. So really, I wouldn't read too much into the lung, dynamic. I think most, frankly speaking, most of the lung centers were waiting to see, the FDA approval to start, launching into de novo. The heart, I would say, has a similar impact, but also there has been a couple of other, activities and trials wrapping up, in the second half of 2025 that may have played a role. One is the cold perfusion trial, but that's wrapped up, and then the other one is a couple of centers decided to do, something, that they are doing organically, and that again, we will address all these dynamics at the ISHLT symposium. As we sit here, we don't, we any of these dynamics, we believe wholeheartedly it's transient in nature, and, all that's going to get washed with enhanced firing up and de novo hopefully, getting initiated here pretty soon, so. We're looking forward to seeing the impact of, enhanced Part A and Part B, and hopefully we can reverse that, these dynamics, throughout 26 and into 27.

    克里斯,謝謝你的提問,答案是肺。肺,因為它是我們周圍的區域。所以,我真的不會對肺部動態進行過多解讀。坦白說,我認為大多數肺科中心都在等待 FDA 的批准,然後再開始進行從頭開始的治療。我認為,心臟也有類似的影響,但 2025 年下半年還有一些其他的活動和試驗即將結束,這可能也起到了一定的作用。一項是冷灌注試驗,但該試驗已經結束;另一項是幾個中心決定做一些事情,他們正在自發性地進行,我們將在 ISHLT 研討會上討論所有這些動態。我們現在坐在這裡,我們並不認為這些動態是暫時的,我們完全相信這一切都是暫時的,而且所有這些都將被增強的活力和新的希望所取代,希望很快就能在這裡啟動。我們期待看到增強後的 A 部分和 B 部分的影響,並希望我們能夠扭轉這種局面,在 2026 年和 2027 年繼續保持這種動態。

  • Operator

    Operator

  • We don't have any further questions. That concludes our question-and-answer session. I will now pass it back over to our CEO Waleed Hassani for closing remarks.

    我們沒有其他問題了。我們的問答環節到此結束。現在我將把發言權交還給我們的執行長瓦利德·哈薩尼,請他致閉幕詞。

  • Waleed Hassanein - President and Chief Executive Officer

    Waleed Hassanein - President and Chief Executive Officer

  • Thank you all very much. I'm looking forward to speaking again, to report on Q1 results. Have a wonderful evening everyone.

    非常感謝大家。我期待再次發言,報告第一季業績。祝大家晚上愉快。

  • Thank you.

    謝謝。

  • Operator

    Operator

  • The meeting has now concluded.

    會議已經結束。

  • Thank you all for joining. You may now disconnect.

    感謝各位的參與。您現在可以斷開連線了。

  • Waleed Hassanein - President and Chief Executive Officer

    Waleed Hassanein - President and Chief Executive Officer

  • Thank you, operator.

    謝謝接線生。